A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma.

Trial Profile

A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma.

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2016

At a glance

  • Drugs Reslizumab (Primary)
  • Indications Asthma; Eosinophilia
  • Focus Registrational; Therapeutic Use
  • Acronyms BREATH
  • Sponsors Cephalon; Teva Branded Pharmaceutical Products R&D
  • Most Recent Events

    • 18 Aug 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700194103, 700194191, 700212125 & 700194454) the European Commission has granted marketing authorization for reslizumab for the treatment of asthma.
    • 24 Jun 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700194103, 700194191, 700212125 & 700194454) the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for reslizumab for the treatment of severe eosinophilic asthma. The final decision by the European Commission is expected in the second half of 2016.
    • 28 Apr 2016 Time frame of the primary end point changed from only 16 weeks to Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top